Why is Europe ‘reinventing the wheel’ with EMDN? Why not use the already widely adopted GMDN system?
For many years, Global Medical Device Nomenclature (GMDN) codes were the de facto system for categorizing medical devices in Europe. The GMDN database is extensive and recognized by many international regulators, including European Competent Authorities for over a decade.
So — if use of the GMDN system is prevelant in Europe, and the MDR/IVDR requires a nomenclature system as part of its medical device database (EUDAMED), why isn’t Europe using GMDN codes?
The MDR/IVDR stress that the nomenclature system should be free of charge.
While the GMDN Agency does have a Basic membership level available for free, higher levels of membership require payment of an annual fee. The fee varies depending on the size and type of organization.
As a result, the Commission decided to instead develope a European Medical Device Nomenclature (EMDN) system instead.